- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00605046
Evaluation of [123I] AV151 and SPECT in Subjects w/ AD in Comparison to Healthy Subjects (AV151)
Evaluation of [123I] AV151 and SPECT as a Marker of Beta-amyloid Protein Deposition in Subjects With Alzheimer Disease (AD) in Comparison to Healthy Subjects
Purpose:
The main objectives of this proposal are as follows:
To assess the dynamic uptake and washout of 123-I AV151, a potential imaging biomarker for β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in similarly aged healthy controls and Alzheimer's (AD) subjects
To perform blood metabolite characterization of 123-I AV151 in healthy and AD subjects to determine the metabolic fate and nature of metabolites in assessment of 123-I AV151 as a single photon computed tomography (SPECT) brain imaging agent
Evaluate the test/retest reproducibility of 123-I AV151 and SPECT in AD subjects and healthy controls
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06510
- Institute for Neurodegenerative Disorders
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New Haven, Connecticut, United States, 06510
- Molecular NeuroImaging, LLC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA: ALZHEIMER DISEASE
- The participant is 50 years or older.
- Written informed consent is obtained.
- Participants have a clinical diagnosis of Alzheimer's disease based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria.
- Mini-Mental Status Exam score < 25.
- Modified Hachinski Ischemia Scale score of ≤ 4.
- Geriatric Depression Scales (GDS) ≤ 10.
- For females, non-child bearing potential or negative urine or blood pregnancy test on day of 123-I AV151 injection.
EXCLUSION CRITERIA: ALZHEIMER DISEASE
- The subject has signs or symptoms of another neurodegenerative disease including Parkinson's disease, diffuse Lewy body dementia, or history of significant cerebrovascular disease.
- The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
- The subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery).
- The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- Pregnancy
Concomitant therapy Patients may remain on a stable dose of anticholinesterase medication during the study. Use of donepezil (Aricept®), rivastigmine (Exelon®), galantamine (Razadyne®), tacrine (Cognex®), and memantine (Namenda®) are permitted during the study. Doses of these compounds must be stable for 2 months prior to the study. At each visit after the screening visit, the investigator will ask the patient whether any medications including OTC medications, were taken since the previous visit.
Use of antipsychotics for agitation and benzodiazepines for insomnia or anxiety is permitted. However, the use of these agents is not permitted within the 8 hours prior to administration of cognitive testing.
INCLUSION CRITERIA: HEALTHY VOLUNTEERS
- The participant is 50 years or older.
- Written informed consent is obtained.
- Negative history of neurological or psychiatric illness based on evaluation by a research physician.
- Mini-Mental Status Exam score ≥28.
- For females, non-child bearing potential or negative urine or blood pregnancy test on day of 123-I AV151 injection.
EXCLUSION CRITERIA: HEALTHY VOLUNEERS
- The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.
- The subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery).
- The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Asses [123I] AV151 and SPECT imaging
|
AV151-01: Evaluation of [123I] AV151 and SPECT as a marker of beta-amyloid protein deposition in subjects with Alzheimer disease in comparison to healthy subjects
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AV151-01: Evaluation of [123I] AV151 and SPECT as a marker of beta-amyloid protein deposition in subjects with Alzheimer disease in comparison to healthy subjects
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AV151
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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